Constriction device viewable under X ray fluoroscopy

ABSTRACT

A constriction device that constricts body tissue is viewable under X ray fluoroscopy. The device includes an elongated sleeve. The sleeve includes opposed opened ends and is formed from expandable or elastic material to receive therein, when in an expanded condition, body tissue to be constricted and to constrict the body tissue therein when released from the expanded condition. At least a portion of the sleeve includes X ray opaque material rendering the device visible under X ray fluoroscopy.

RELATED APPLICATIONS

This present application is a continuation of U.S. application Ser. No.09/901,764, filed Jul. 10, 2001, the entire contents of which isincorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention is generally directed to a constricting devicethat constricts body tissue. The present invention is more particularlydirected to a constricting device which is viewable under X rayfluoroscopy.

Constriction devices have been contemplated for constricting bodytissue. Such devices have been considered for use, for example, intissue resection procedures and in treating pulmonary disease.

Chronic Obstructive Pulmonary Disease (COPD) has become a major cause ofmorbidity and mortality in the United States over the last threedecades. COPD is characterized by the presence of airflow obstructiondue to chronic bronchitis or emphysema. The airflow obstruction in COPDis due largely to structural abnormalities in the smaller airways.Important causes are inflammation, fibrosis, goblet cell metaplasia, andsmooth muscle hypertrophy in terminal bronchioles.

The incidence, prevalence, and health-related costs of COPD are on therise. Mortality due to COPD is also on the rise. In 1991 COPD was thefourth leading cause of death in the United States and had increased 33%since 1979.

COPD affects the patient's whole life. It has three main symptoms:cough; breathlessness; and wheeze. At first, breathlessness may benoticed when running for a bus, digging in the garden, or walking uphill. Later, it may be noticed when simply walking in the kitchen. Overtime, it may occur with less and less effort until it is present all ofthe time.

COPD is a progressive disease and currently has no cure. Currenttreatments for COPD include the prevention of further respiratorydamage, pharmacotherapy, and surgery. Each is discussed below.

The prevention of further respiratory damage entails the adoption of ahealthy lifestyle. Smoking cessation is believed to be the single mostimportant therapeutic intervention. However, regular exercise and weightcontrol are also important. Patients whose symptoms restrict their dailyactivities or who otherwise have an impaired quality of life may requirea pulmonary rehabilitation program including ventilatory muscle trainingand breathing retraining. Long-term oxygen therapy may also becomenecessary.

Pharmacotherapy may include bronchodilator therapy to open up theairways as much as possible or inhaled .beta.-agonists. For thosepatients who respond poorly to the foregoing or who have persistentsymptoms, Ipratropium bromide may be indicated. Further, courses ofsteroids, such as corticosteroids, may be required. Lastly, antibioticsmay be required to prevent infections and influenza and pheumococcalvaccines may be routinely administered. Unfortunately, there is noevidence that early, regular use of pharmacotherapy will alter theprogression of COPD.

Lung transplantation is also an option. Today, COPD is the most commondiagnosis for which lung transplantation is considered. Unfortunately,this consideration is given for only those with advanced COPD. Given thelimited availability of donor organs, lung transplant is far from beingavailable to all patients.

About 40 years ago, it was first postulated that the tethering forcethat tends to keep the intrathoracic airways open was lost in emphysemaand that by surgically removing the most affected parts of the lungs,the force could be partially restored. Although the surgery was deemedpromising, the procedure was abandoned.

The lung volume reduction surgery (LVRS) was later revived. In the early1990's, hundreds of patients underwent the procedure. However, theprocedure has fallen out of favor due to the fact that Medicare stoppedremitting for LVRS. Unfortunately, data is relatively scarce and manyfactors conspire to make what data exists difficult to interpret. Theprocedure is currently under review in a controlled clinical trial.However, what data does exist tends to indicate that patients benefitedfrom the procedure in terms of an increase in forced expiratory volume,a decrease in total lung capacity, and a significant improvement in lungfunction, dyspnea, and quality of life.

Improvements in pulmonary function after LVRS have been attributed to atleast four possible mechanisms. These include enhanced elastic recoil,correction of ventilation/perfusion mismatch, improved efficiency ofrespiratory musculature, and improved right ventricular filling.

The improvements in pulmonary function resulting from LVRS cannot beignored. However, the surgery is very invasive and fraught withcomplications. Among the complications is the potential for lung airleaks. Lung tissue is very thin, and fragile hence difficult to suturetogether. After a lung portion is sectioned and removed, the remaininglung is most often restructured with suture staples. In about thirtypercent (30%) of the cases, the difficulty with suturing lung tissueresults in air leaks. Treatment for such air leaks depends upon theirseverity and often, in the most serious cases, requires further openchest surgery.

Air leaks in lungs can be caused by other causes. With increasing age, apatient may develop a weakened section of lung which may then rupturedue to an extreme pressure differential, such as may result from simplya hard sneeze. AIDS patients can suffer from air leaks in their lungs.Air leaks in lungs can further be caused by a puncture from a broken ribor a stab wound.

The invention disclosed and claimed in copending U.S. application Ser.No. 09/534,244, incorporated herein by reference, provides an improvedtherapy for treating COPD and air leaks in lungs. The therapy includes aconstriction device which, when deployed on a lung, suppresses air leaksin the lung tissue without requiring any suturing of the effected lungtissue. Still further, by constricting a large enough portion of a lungwith the device, lung volume reduction with the concomitant improvedpulmonary function may be obtained without the need for any suturing oflung tissue at all.

The lung constriction device includes a jacket or sheath of flexiblematerial configured to cover at least a portion of a lung. The jackethas a pair of opened ends to permit the lung portion to be drawn intothe jacket. The jacket is dimensioned to constrict the lung portionafter the lung portion is drawn therein. The lung constriction device ispreferably formed of expandable, such as elastic, material for receivingthe lung tissue while the device is in an expanded or enlargedcondition, and then contractible about the lung portion upon release ofthe expanded condition for constricting the lung tissue.

An important aspect of the device and method disclosed in U.S.application Ser. No. 09/534,244 is the ability to sever the constrictingdevice intermediate its ends. This allows a significant portion of theconstricted lung tissue to be removed altogether while permitting aportion of the constricting device to remain in the body for continuedsuppression of air leaks and maintenance of the remaining lung tissueintegrity.

Devices and methods similar to those disclosed in U.S. application Ser.No. 09/534,244 may be employed to advantage in other and differentprocedures such as in general resection procedures and for body tissueother than lung tissue. Resection procedures are commonly performed forsuch body tissue as, for example, atrial appendage tissue, ovariantissue, gall bladder tissue, pancreatic tissue, appendix tissue andspleen tissue. Resection procedures may be required to treat cancer,organ damage, or organ disease, for example.

U.S. application Ser. No. 09/534,244 also discloses and claims variousmethods and apparatus for deploying the constricting device on bodytissue such as lung tissue. One apparatus and method contemplatesmechanically expanding the device in a transverse dimension whilephysically pulling the tissue to be constricted into the device.

Another method contemplates mounting the device over a vacuum chamberand pulling the tissue into the vacuum chamber by engaging the tissuewith an opened end of the chamber and then drawing a vacuum in thechamber. This draws the tissue into the chamber. Then, the chamber iswithdrawn from the device, leaving the tissue constricted in the device.

A further method contemplates inserting the device into a vacuum chamberand sealing the opened end of the chamber to the device. The opened endof the chamber and the tissue are then brought into sealing engagement.A vacuum is next pulled in the chamber and the device to pull the tissueinto the device and chamber. Once the tissue is within the device, thechamber is removed from over the device leaving the tissue constrictedin the device.

U.S. application Ser. No. ______ (case 1759-7), incorporated herein byreference, discloses and claims another apparatus and method fordeploying a constriction device on body tissue. Dual vacuums allowhigher constriction volumes and higher applied constriction forces.

The apparatus includes an elongated housing that receives theconstriction device longitudinally therein. A first opening sealable toa first opening of the device and a second opening sealable to a secondopening of the device forms a sealed space external to the device withinthe housing. The apparatus further includes a first vacuum source thatpulls a first vacuum within the sealed space, and a second vacuum sourcethat pulls a second vacuum through the second opening when the bodytissue is brought into engagement with the first opening of the device.The first vacuum serves to expand the device while the second vacuumserves to pull the body tissue into the device.

Although various methods and apparatus have been conceived foreffectively deploying constriction devices on body tissues, theconstriction devices, over time, may become dislodged due to the natureof the soft tissue on which they are deployed. More specifically, softbody tissue has a tendency to expand at the proximal end of the devicecausing longitudinal slippage of the device on the body tissue. This mayeventually lead to the device slipping totally free from the tissue.Hence, there is a need for additional constriction device structure forfixing the device on the tissue.

In addition, some contemplated uses of the constriction devices, such asin effecting a reduction in lung volume, require that the device remainon the tissue for an indeterminate period of time. Once the patient hasrecovered from the deployment procedure, it would be helpful to be ableto determine that the device has remained in position. Hence, there is aneed for such a device to be visible by the physician in some mannerlong after the deployment procedure has taken place.

The present invention addresses these needs. It provides a constrictiondevice having positive fixation structure for maintaining theconstriction device deployed on the body tissue. The present inventionfurther renders it possible to determine the position of the devicewithin the body to permit medical personnel to confirm that the devicehas remained in place and that it continues to be effective. Inaccordance with particular aspects of the present invention, it is thefixation structure which also renders it possible to determine theposition of the device.

SUMMARY OF THE INVENTION

The invention provides a constriction device that constricts body tissueand which is visible under X ray fluoroscopy. The device includes anelongated sleeve having opposed opened ends and being formed fromexpandable material to receive therein, when in an expanded condition,body tissue to be constricted and to constrict the body tissue thereinwhen released from the expanded condition. At least a portion of thesleeve is visible under X ray fluoroscopy.

The sleeve further includes an outer surface and a coating of X rayopaque material on the outer surface to form the portion of the sleevevisible under X ray fluoroscopy. The sleeve also has a longitudinaldimension between the opposed opened ends and the coating of X rayopaque material may include strips of X ray opaque material along thelongitudinal dimension of the sleeve. Alternatively, the X ray opaquematerial may be embedded in the side wall to form the portion of thesleeve visible under X ray fluoroscopy. The embedded X ray opaquematerial may be configured in strips extending within the sleeve sidewall along the longitudinal dimension of the sleeve.

The sleeve may further include an inner surface and X ray opaquematerial may be on the inner surface to form the portion of the sleevevisible under X ray fluoroscopy. The X ray opaque material may again beconfigured as strips of X ray opaque material along the longitudinaldimension of the sleeve.

The sleeve may include a plurality of X ray opaque elements to form theportion of the sleeve visible under X ray fluoroscopy. The X ray opaqueelements may be adjacent to one of the opposed openings and in aside-by-side relation.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel areset forth with particularity in the appended claims. The invention,together with further objects and advantages thereof, may best beunderstood by making reference to the following description taken inconjunction with the accompanying drawings, in the several figures ofwhich like reference numerals identify identical elements, and wherein:

FIG. 1 is a simplified sectional view of a thorax illustrating arespiratory system having a constricting device embodying the presentinvention deployed on a portion of a lung to effect lung volumereduction;

FIG. 2 is a sectional view similar to FIG. 1 but illustrating therespiratory system after the constricted lung portion has beenresectioned;

FIG. 3 is a perspective view illustrating a constricting deviceembodying the present invention;

FIG. 4 is a side view of a constriction device including X ray visibleelements in accordance with another embodiment of the present invention;

FIG. 5 is a sectional view taken along lines 5-5 of FIG. 4;

FIG. 6 is a perspective view of another constriction device embodyingthe present invention having fixation elements on an inside surfacethereof wherein the fixation elements may be formed of material visibleunder X ray fluoroscopy in accordance with the present invention;

FIG. 7 is a perspective view of another constriction device embodyingthe present invention;

FIG. 8 is a perspective view of fixation elements which may be employedin accordance with the present invention;

FIG. 9 is a perspective view of another constriction device embodyingthe present invention;

FIG. 10 is a partial end view of the constriction device of FIG. 10illustrating the manner in which the fixation elements function prior tothe collapse of the constriction device;

FIG. 11 is another partial end view of the constriction device of FIG.10 illustrating the manner in which the fixation elements grasp theconstricted tissue upon collapse of the constriction device;

FIG. 12 is a sectional side view of another constriction deviceembodying the present invention;

FIG. 13 is a side view of a mandrel which may be used in making theconstriction device of FIG. 13; and

FIG. 14 is a sectional side view of the mandrel of FIG. 13 at anintermediate stage in the making of the constriction device of FIG. 13.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to FIG. 1, it is a sectional view of a respiratory system20. The respiratory system 20 resides within the thorax 22 whichoccupies a space defined by the chest wall 24 and the diaphragm 26.

The respiratory system 20 includes the trachea 28, the left mainstembronchus 30, the right mainstem bronchus 32, and the bronchial branches34, 36, 38, 40, and 42. The respiratory system 20 further includes leftlung lobes 52 and 54 and right lung lobes 56, 58, and 60. Each bronchialbranch communicates with a respective different portion of a lung lobe,either the entire lung lobe or a portion thereof.

A healthy respiratory system has an arched or inwardly arcuate diaphragm26. As the individual inhales, the diaphragm 26 straightens to increasethe volume of the thorax 22. This causes a negative pressure within thethorax. The negative pressure within the thorax in turn causes the lunglobes to fill with air to an inflated condition. When the individualexhales, the diaphragm returns to its original arched condition todecrease the volume of the thorax. The decreased volume of the thoraxcauses a positive pressure within the thorax which in turn causesexhalation of the lung lobes.

FIG. 1 also shows a constriction device 70 embodying the presentinvention deployed on lobe 58. The device 70 is configured as a sleeveor sheath formed of a sheet of flexible or elastic biocompatiblematerial. The material may be formed from silicone rubber, polyurethane,expanded polytetraflouroethylene, polyester and polyurethane, or nylonand polyurethane, for example. It may alternatively be flexible butnonexpandable formed from nylon, polytetraflouroethylene, or polyester,for example. If the sleeve is expandable, it may more specifically beformed from a sheet or fabric of 70% nylon and 30% polyurethane. Thesleeve is preferably opened at both ends and may be generallycylindrical in configuration.

As will be seen subsequently, in accordance with the preferredembodiment of the present invention, the sleeve is applied to the lunglobe while in an expanded condition. This may be accomplished, asdisclosed in U.S. patent application Ser. No. ______ (case 1759-7), byexpanding the sleeve with a first vacuum and then pulling the lungportion into the sleeve with a second vacuum. When the lung portion iswithin the sleeve, the expansion of the device is released. With theexpansion released, the sleeve is permitted to contract or collapseabout the lung portion to constrict the lung portion.

The device 70 may be employed, for example, to suppress air leakages inlungs. It may also find use to advantage in constricting a lung portionsuffering from COPD to simulate or achieve lung volume reduction. All ofthe beneficial effects of lung volume reduction surgery may be realizedand, most importantly, without requiring suturing of lung tissue.

In accordance with the present invention, the constriction device 70includes a plurality of coated strips 71 on the outer surface of thedevice 70. The strips are formed from gold, for example, to render thedevice visible under X ray fluoroscopy. This makes it possible for thephysician to confirm at a later time that the device has maintained itsposition on the lung tissue 58.

FIG. 2 shows the respiratory system 20 after the constricted lungportion has been resectioned. The device 70 is preferably formed ofseverable material, such as, any of the materials previously described.This enables the device 70 to be severed or cut intermediate its endswith a suitable bladed instrument to resection the lung lobe 58. Theportion of the device 70 remaining on the lobe 58 continues to constrictthe lung tissue therein to form an effective seal from leakage. Thestrips 71 are coated on the device 70 to extend from the proximal end ofthe device. This enables at least portions of the strips 71 to remainafter resectioning to permit the device to be visible under X rayfluoroscopy for future confirmation that the device 70 remains in placeon the lung tissue. Hence, lung volume reduction is rendered anavailable treatment while negating the need of conventional lungsectioning and suturing thus avoiding the potentially severecomplications which accompany those procedures.

FIG. 3 illustrates the constricting device 70 in greater detail. Thedevice 70 is a generally cylindrical sleeve having a longitudinaldimension 72 and a transverse dimension 74. As previously mentioned, thedevice 70 is preferably formed of an elastic material permitting thedevice to expand in the longitudinal dimension and more importantly inthe transverse dimension. The device 70 has opposed opened ends 76 and78. The device may further include at each end 76 and 78 an integral rim80 and 82 respectively.

The strips 71 of X ray opaque material extend longitudinally along theouter surface of the device 70. The strips 71 also extend from theopening 78 which, when deployed on the lung tissue 58, is at theproximal end of the device. This enables the strips 71 to remain on thedevice within the patient's body even though the device may be severedfor resectioning the lung tissue or any other tissue on which the device70 is deployed.

FIGS. 4 and 5 illustrate another constriction device 90 embodying thepresent invention. Like the device 70, the device 90 is a sleevegenerally cylindrical in configuration having opposed opened ends 92 and94. Embedded within the longitudinal side wall 96 of the device 90, andextending longitudinally there along, are a plurality of strips 98 of Xray opaque material. The strips 98, again, may be formed of gold, forexample, or any other material known in the art which is visible under Xray fluoroscopy.

Like the strips 71 of the device 70, the strips 98 of the device 90extend from an opened end 92. By extending longitudinally, the strips 98permit the device 90 to expanding transversely or radially outwardlyduring the deployment of the device 90. Once the device collapses aboutthe tissue to be constricted, the strips may be seen under X rayfluoroscopy to confirm its position with the patient's body.

FIG. 6 illustrates another constriction device 100 embodying the presentinvention. The device 100 again is a generally cylindrical sleeve havingopposed opened ends 102 and 104. Adjacent the opened end 102 and on theinner surface 106 of the sleeve are a plurality of fixation elements108. In accordance with this embodiment, the fixation elements areelongated bars arranged adjacent each other and circumscribing theopening 102. The fixation elements are closely spaced. When the device100 is expanded to receive the tissue to be constricted, the tissue atleast partially fills the spaces between adjacent fixation elements.Then, when the device 100 is permitted to collapse about the tissue tobe constricted, adjacent fixation elements move toward each to grasp thetissue. This provides positive fixation of the device on the constrictedtissue and serves to resist migration or movement of the device in alongitudinal direction to maintain the device in a fixed position on thetissue.

The fixation elements 108 are preferably formed of an X ray opaquematerial such as gold or stainless steel, for example. Again, this makesit possible to discern the position of the device 100 under X rayfluoroscopy. Hence, in accordance with this embodiment, the fixationelements served a dual purpose, fixing the device 100 on the constrictedtissue and rendering at least a portion of the device visible under Xray fluoroscopy.

FIG. 7 illustrates another constriction device 110 embodying the presentinvention. The device 110 again is a generally cylindrical sleeve havingopposed opened ends 112 and 114. Adjacent the opened end 112 and on theinner surface 116 of the sleeve are a plurality of fixation elements118. In accordance with this embodiment, the fixation elements take theform of wires or elongated pins. The fixation elements are arrangedadjacent each other and circumscribe the opening 112. The fixationelements are closely spaced and function in the same manner as thefixation bars 108. Hence, when the device 110 is expanded to receive thetissue to be constricted, the tissue at least partially fills the spacesbetween adjacent pins. Then, when the device 110 is collapsed about thetissue to be constricted, adjacent pins move toward each to grasp thetissue. This again provides positive fixation of the device on theconstricted tissue.

Again, the pins 118 are preferably formed of an X ray opaque materialsuch as gold or stainless steel, for example. This makes it possible todiscern the position of the device 100 under X ray fluoroscopy. Hence,in accordance with this embodiment, the pins serve the dual role offixing the device 110 on the constricted tissue and rendering at least aportion of the device visible under X ray fluoroscopy.

As may be best seen in FIG. 8, the pins 118 may be provided withprojecting barbs 119. The barbs 119 promote the grasping of theconstricted tissue and provide additional gripping action formaintaining the device 110 in a fixed position once deployed.

FIG. 9 illustrates still another constriction device 120 embodying thepresent invention. Again, the device 120 is a generally cylindricalsleeve having opposed opened ends 122 and 124. Adjacent the opened end122 and on the inner surface 126 of the sleeve are a plurality offixation elements 128. In accordance with this embodiment, the fixationelements are generally square shaped pads arranged in rows adjacent eachother and circumscribing the opening 122. As in the previousembodiments, the fixation elements are closely spaced. As may be bestseen in FIG. 10, when the device 120 is expanded to receive the tissue58 to be constricted, the tissue at least partially fills the spaces,such as space 129, between adjacent fixation elements. Then, when thedevice 120 is permitted to collapse about the tissue to be constrictedas may best be seen in FIG. 11, adjacent fixation elements 128 movetoward each other to grasp the tissue. This again provides positivefixation of the device on the constricted tissue and serves to resistmigration or movement of the device in a longitudinal direction tomaintain the device in a fixed position on the tissue.

The fixation elements 128 are again preferably formed of an X ray opaquematerial such as gold or stainless steel, for example. Again, this makesit possible to discern the position of the device 100 under X rayfluoroscopy. Hence, the fixation elements 128 fix the device 120 on theconstricted tissue and render at least a portion of the device 120visible under X ray fluoroscopy.

As may also be noted in FIGS. 10 and 11, the fixation elements 128 maybe provided with a roughened surface 127. This further promotes grippingof the tissue 58 by the fixation elements 128.

FIG. 12 illustrates another constriction device 130 embodying thepresent invention. Again, the device 130 is a generally cylindricalsleeve having opposed opened ends 132 and 134. In accordance with thisembodiment, the fixation elements are integral to and within thelongitudinal side wall 136 of the device 130. More specifically, thefixation elements take the form of integral protrusions 138 extendinginwardly from the inner surface 135 of the device 130. The protrusions138 serve to grasp the constricted tissue when the device is permittedto collapse about the tissue.

FIG. 13 illustrates a mandrel 140 which may be used in making theconstriction device 130 of FIG. 12. The mandrel 140 is generallycylindrical in configuration and includes on its outer surface 142 aplurality of semispherical indentations or divots 144.

The device 130 may be made by using the mandrel 140 in a dippingprocess. Here, the mandrel is dipped into a liquid material, such asliquid silicone rubber which is elastic when hardened. After at leasttwo such dips, the assembly of FIG. 13 will appear as shown in FIG. 14.The mandrel 140 is now covered by a silicone rubber film. Into eachsemispherical divot of the film a hardened or solid sphere 148 isplaced. Then, the assembly of FIG. 14 is once again subjected tomultiple additional dips into the liquid silicone rubber until the sidewall of the device 130 is built up to a suitable thickness, such as, forexample, 0.015 inches. The resulting film is then permitted to harden.Once hardened, the end panels are cut away to form the opposed openedends 132 and 134 and the film is removed from the mandrel. What remainsis the device 130 of FIG. 12.

Preferably, the solid spheres 148 are formed of a material opaque to Xrays. Such a material may, for example, be gold or stainless steel. Thisrenders the device 130 at least partially visible under X rayfluoroscopy. As a result, the device 130 is provided with a fixationstructure in the form of integral protrusions 138 while also beingprovided with X ray visible elements.

While the invention has been described by means of specific embodimentsand applications thereof, it is understood that numerous modificationsand variations could be made thereto by those skilled in the art withoutdeparting from the spirit and scope of the invention. It is therefore tobe understood that within the scope of the claims, the invention may bepracticed otherwise than as specifically described herein.

1. A constriction device that constricts body tissue comprising anelongated sleeve, the sleeve including opposed opened ends and beingformed from expandable material to receive therein, when in an expandedcondition, body tissue to be constricted and to constrict the bodytissue therein when released from the expanded condition, at least aportion of the sleeve being visible under X ray fluoroscopy.
 2. Thedevice of claim 1 wherein the sleeve further includes an outer surfaceand a coating of X ray opaque material on the outer surface to form theportion of the sleeve visible under X ray fluoroscopy.
 3. The device ofclaim 2 wherein the sleeve has a longitudinal dimension between theopposed opened ends and wherein the coating of X ray opaque materialcomprises strips of X ray opaque material along the longitudinaldimension of the sleeve.
 4. The device of claim 1 wherein the sleeveincludes a side wall extending between the opposed opened ends and X rayopaque material embedded in the side wall to form the portion of thesleeve visible under X ray fluoroscopy.
 5. The device of claim 4 whereinthe side wall defines a longitudinal dimension of the sleeve, andwherein the X ray opaque material comprises strips of X ray opaquematerial embedded in the side wall along the longitudinal dimension ofthe sleeve.
 6. The device of claim 1 wherein the sleeve further includesan inner surface and X ray opaque material on the inner surface to formthe portion of the sleeve visible under X ray fluoroscopy.
 7. The deviceof claim 6 wherein the sleeve has a longitudinal dimension between theopposed opened ends and wherein the X ray opaque material comprisesstrips of X ray opaque material along the longitudinal dimension of thesleeve.
 8. The device of claim 1 wherein the sleeve includes a pluralityof X ray opaque elements to form the portion of the sleeve visible underX ray fluoroscopy.
 9. The device of claim 8 wherein the X ray opaqueelements are adjacent to one of the opposed openings.
 10. The device ofclaim 8 wherein the X ray opaque elements are arranged in a side-by-siderelation.
 11. The device of claim 8 wherein the sleeve includes an innersurface and wherein the X ray opaque elements are on the inner surfaceof the sleeve.
 12. The device of claim 11 wherein the X ray opaqueelements are adhered to the inner surface of the sleeve.
 13. The deviceof claim 11 wherein the X ray opaque elements are adjacent to one of theopposed openings.
 14. A constriction device that constricts body tissuecomprising sleeve means including opposed opened ends and formed fromexpandable material to receive therein, when in an expanded condition,body tissue to be constricted and to constrict the body tissue thereinwhen released from the expanded condition, and X ray opaque means torender the device visible under X ray fluoroscopy.